MAUDE Adverse Event Report: SYNTHES GMBH 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 20; SCREW, FIXATION, BONE

Model Number	02.211.020
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: additional device product code: (b)(4).Reporter is a j&j sales representative.Investigation summary: investigation flow: damage.Visual inspection: the 2.7 va lckng scr slf-tpng t8 sd rec 20 (p/n: 02.211.020, lot number: unk) was received at us cq.Visual inspection of the complaint device showed some damage to the threads.The device failure/defect was identified.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.The complaint was confirmed.Investigation conclusion: this complaint is confirmed as the threads were damaged.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, a patient underwent the revision procedure of a tmt-1 due to pseudarthrosis.Initial procedure was performed on (b)(6) 2020 with arthrodesis with 2.7mm variable angle (va) x-plate.Postoperatively, one (1) 2.7mm va locking screw was also broken in the shaft of the screw.The screw was partially explanted during revision procedure.The screw shaft remained in the bone, based on surgeons decision not to remove the broken shaft.Revision was successfully completed without any issue.There was no surgical delay.No further information provided.This report is for one (1) 2.7 va lckng scr slf-tpng t8 sd rec 20.This is report 2 of 3 for complaint (b)(4).

• Brand Name: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 20
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11792533
• Report Number: 8030965-2021-03709
• Device Sequence Number: 19800679
• Product Code: HWC
• UDI-Device Identifier: 10886982053619
• UDI-Public: 10886982053619
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.211.020
• Device Catalogue Number: 02.211.020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 100